The present invention relates generally to interventional medicine, and particularly concerns properly locating, vectoring, and inserting a needle-like medical device toward and into a targeted patient anatomic feature while the patient is being imaged with single, or multi-modality medical imaging equipment such as computed tomography imaging (CTI) equipment, magnetic resonance imaging equipment (MRI), fluoroscopic imaging equipment, and 3D ultrasound equipment.
Among others, Frank J. Bova and William A. Friedman of the present inventors have pioneered the art of high precision planning and treatment of intracranial targets using radiation originating from medical linear accelerators. All of these previously developed planning and treatment systems have been based upon a rigid model consisting of the patient""s skull, upper dentisia and intracranial anatomy. Exemplary of these systems and methods are those described in U.S. patent application Ser. No. 09/621,868, filed Jul. 21, 2000, and in the following U.S. Pat. Nos., all issued to the Bova and Friedman on the indicated dates, assigned to the assignee of the present application, the entire contents and disclosures of all of which are incorporated herein by reference:
Although this rigid model is valid for cranial targets, it is not practical for all anatomic regions. An example of a target that cannot be modeled with a rigid body modality is metastatic disease within the liver. In order to effect the application of high precision biopsy, radiation treatments or other medical procedures to such deformable anatomic regions, real time imaging of the target region must be incorporated into the treatment procedure.
Multiplanar x-rays and ultrasound are the best suited of all of the modalities available for such real time imaging. Multiplanar x-ray imaging, primarily orthogonal imaging, has been used to localize radiation targets for several decades. While this mode of target localization has several advantages, its primary disadvantages are the space and time it requires. The space required by the imaging chain, including x-ray source(s) and imaging electronics, is simply not available near or around a patient who is in position for real time treatment, especially if the treatment uses a medical linear accelerator. Depending on how fast an image of a given portion of the anatomy changes with time and the time required to complete a multiplanar x-ray process, the x-ray imaging may not be sufficiently fast to track changes and provide accurate real time data.
U.S. Pat. No. 5,893,832, issued to Song on Jun. 24, 1997, describes an ultrasound probe which provides a 3D image of an anatomic region without external probe movement. The probe effectively provides a 3D image of a selected anatomic region without the necessity for external probe movement. Ultrasound probes like those of the Song patent can provide real time imaging of a portion of the patient""s anatomy, although the image data is with reference to the position of the ultrasound probe. As the ultrasound probe is moved, the point of reference changes.
U.S. patent application Ser. No. 09/621,868, filed Jul. 21, 2000 describes a system which enables image guidance during radiation therapy and surgery, by combining an ultrasound probe with both passive and active infrared tracking systems for production of a 3D image. The combined system enables a real time image display of the entire region of interest without probe movement. The system enables probe displacement during image acquisition so that all external displacements introduced by the probe can be accounted for at the time of placement of elements in support of a treatment protocol. This is accomplished by registration of a patient""s real world anatomy with the patient""s virtual world imaging study. The coordination of these two worlds allow for a clinician to perform a procedure in the virtual world and then, with the aid of computer guidance execute the procedure in the real world.
The first application of linking the real world with the virtual world was the establishment of stereotactic neurological procedures based upon rigid stereotactic frames. Frameless virtual guidance technology has also been established for several operative environments. Intracranial procedures, based upon CTI and or MRI scans have been available for several years. The same CTI or MRI based guidance have also been available for planning and guidance in spinal surgery. Recently, imaging support for the virtual environment has been extended to include virtual fluoroscopy. At the University of Florida the incorporation of both 2D and 3D ultrasound has now been made available for virtual procedures. This form of guidance is employed in many daily procedures including brain tumor biopsy, brain tumor resection, deep brain stimulation, pallidotomy for Parkinson""s disease, lesioning procedures for pain, pedicle screw fixation, guidance for ENT surgical procedures, radiosurgery and stereotactic radiotherapy.
What is needed, is the extension of this technology to image guidance during biopsy. It is desirable to reapply the tools used to project a virtual surgical, or radiation, tool to a biopsy needle. More particularly, it is desirable to apply CTI, MRI, fluoroscopy and ultrasound procedures, either independently or in combination, i.e., multi modality imaging, to guidance and placement of a biopsy needle.
The present invention is described in terms of two embodiments, the first of which is a computer controlled system for guiding a needle device, such as a biopsy needle, by reference to a single mode medical imaging system employing any one of computed tomography imaging (CTI) equipment, magnetic resonance imaging equipment (MRI), fluoroscopic virtual imaging equipment, or 3D ultrasound equipment. The second embodiment is a computer controlled system for guiding the needle device by reference to a multi-modal system, which includes any combination of the above-listed systems.
In the first embodiment, the method of the present invention includes use of a needle device 3D image data set including 3D geometry of the needle device in conjunction with a data set obtained from a single image system, wherein the needle device is configured to be carried by a needle device carrier. The needle device carrier is configured to move in orthogonal coordinate directions relative to a fixed frame of reference so that a current digital positional description of the needle device carrier can be identified with respect to the fixed frame of reference, which is with reference to the real world patient""s position.
A broad description of the first embodiment is directed to the steps of imaging at least a portion of a patient with an imaging device to provide a set of patient imaging data, the set of patient imaging data having a fixed frame of reference relative to the patient, combining an image of the needle device with the set of patient imaging data to provide a combined image data set, calculating a desired combined image data set corresponding to a desired position of the needle device relative to the patient and the fixed frame of reference and causing relative movement between the patient and the needle device, based on the desired combined image data set, to bring the needle device position data set into registry with the desired position of the needle device.
In a more detailed description of the first embodiment, the method includes the step of securing a plurality of patient position markers fixed relative to a patient, the patient position markers defining a fixed frame of reference. At least a part of the patient is imaged using an imaging device to provide a set of patient imaging data, the set of patient imaging data being relative to the fixed frame of reference. The set of patient imaging data includes positional data of the patient position markers when the patient position markers are image-conspicuous, and, alternatively, combined with telemetry fiduciary data when telemetry readouts are arranged to correspond to successive positions of a patient to be scanned. The set of patient imaging data is 3D data derived from 3D imaging systems, including virtual fluoroscopic and 3D ultrasound imaging systems, as well as CTI and MRI imaging systems, and any other 3D system to be developed.
The current position description of the needle device carrier is identified with respect to the fixed frame of reference and a needle position data set is calculated with respect to the fixed frame of reference. A composite data set is calculated by combining the needle device 3D image data set and the 3D patient image data set, wherein the needle device 3D image data set is adjusted with respect to the fixed frame of reference according to the needle position data set. The composite data set is determined from a selected set of co-ordinate locations defining a carrier guide path for movement of the needle device carrier with respect to the fixed frame of reference. The selected set of co-ordinate locations is applied to the needle device carrier so that the needle device moves along a desired needle device guide path corresponding to the carrier guide path.
As in the broad description of the first embodiment, the imaging device of the more detailed description is selected from a group of imaging devices including a computerized tomography imaging device, an magnetic resonance imaging device, a fluoroscopic imaging device, and a 3D ultrasound imaging device that produces 3D imaging data without relative movement between the ultrasound imaging device and the patient. Additionally, the needle device is selected from a group of needle devices including a biopsy needle, a needle configured for injection of toxin into diseased tissue, and an instrument configured for precision placement of a screw, such as a pedicle screw, and the needle device 3D image data set is selected from a group of 3D image data sets including a biopsy needle 3D image data set, an injection needle 3D image data set, and an instrument 3D image data set.
In one embodiment, the patient position markers are secured directly to the patient, and in a separate embodiment, the patent position markers are secured to the scanner table, which supports the patient. Alternatively, the patient position is determined by telemetry.
In the second embodiment of the present invention, there is provided a method and system for properly locating, vectoring, and inserting a needle device toward and into a targeted patient anatomic feature, including imaging at least a portion of a patient with a first imaging technique to provide a first set of imaging data, the first set of imaging data having a fixed frame of reference. In one form of the second embodiment, a second set of imaging data is obtained by a second imaging technique to provide a second set of imaging data, preferably after the first imaging technique is complete. The data sets obtained from the two techniques are then combined to provide a composite data set. Advantageously, if the second imaging technique is both operatively faster and more conducive to the patient treatment environment than the first technique, but is less discriminating than the first imaging technique in terms of image detail, the application of the second imaging data set, as obtained on a substantially real time basis, can be used to update, and effectively determine, a desired selected view obtained from a stored data set from the more detailed first imaging technique.
In a second form of the second embodiment of the present invention, after the above-described first set of imaging data has been obtained, at least a part of the patient is imaged with a second imaging technique which uses an ultrasound device to provide a second set of imaging data, the second set of imaging data being 3D data relative to the ultrasound device and not being fixed relative to the fixed frame of reference. The ultrasound device is operable to provide the 3D data without relative movement between the ultrasound device and the patient, as described in copending U.S. patent application Ser. No. 09/621,868. Position data is determined for the ultrasound device. Using the determined position data and the second set of imaging data, a converted set of imaging data corresponding to the second set of imaging data being referenced to the fixed frame of reference is provided. The converted set of image data is combined with at least some of the first set of imaging data to provide a first composite set of imaging data. An image of the needle device is provided. The image of the needle device is combined with the first composite set of image data to produce a second composite set of image data.
In the second composite set of imaging data the position and orientation of the image of the needle device is identified relative to the image of the at least a portion of the patient and a desired position and orientation of the needle device image corresponding to a desired actual position and orientation of the needle device relative to the patient is determined therefrom. The relative movement between the patient and the needle device is caused to bring the needle device position data set into registry with the desired position and orientation of the needle device.
The first imaging technique, as used to provide the first set of imaging data, is selected from the group consisting of computerized tomography imaging, magnetic resonance imaging, and fluoroscopic imaging. In one method of the invention, the first imaging technique is performed and completed prior to the imaging with the ultrasound device.
The step of imaging with the ultrasound device uses an ultrasound probe that produces 3D imaging data without relative movement between the ultrasonic probe and the patient. The step of determining position data for the ultrasound probe includes determining the position of a plurality of probe position markers on the ultrasound probe, the position of the probe position markers being determined by a technique not including the first and second imaging techniques. The position of the ultrasound probe is determined using infrared (IR) imaging
In the course of a medical procedure employing the present invention, as applied to a patient, an image of the needle device is used in combination with the converted set of imaging data to achieve positioning of the needle device relative to the patient. The needle device is selected from a group of needle devices including a biopsy needle, a needle configured for injection of toxin into diseased tissue, and an instrument configured for precision placement of a screw, and the needle device 3D image data set is selected from a group of 3D image data sets including a biopsy needle 3D image data set, an injection needle 3D image data set, and an instrument 3D image data set.
Relative movement is caused between the patient and the needle device to bring the second set of imaging data into registry with the first set of imaging data. Alternatively, the relative movement is accomplished by controlling the needle device with a robotic guidance apparatus.
The method further includes the step of, at least before completion of the first imaging technique, securing a plurality of patient position markers fixed relative to the patient. Alternatively, the patient position markers are secured to a scanner table for supporting the patient, or they are determined by telemetry or infrared (IR) imaging.
The system of the first embodiment of the present invention provides computer controlled guidance of a needle device including a plurality of patient position markers operable for defining a fixed frame of reference relative to a patient, a needle device, a needle device 3D image data set including 3D geometry of the needle device, and a needle device carrier configured for carrying the needle device for relative movement between the patient and the needle device.
The system also includes a 3D imaging system operable for imaging at least a part of the patient to provide a set of patient 3D imaging data, the set of patient 3D imaging data including positional data of the patient position markers representing a fixed frame of reference when the patient position markers are image-conspicuous, and combined with telemetry fiduciary data when telemetry readouts are arranged to correspond to successive positions of a patient to be scanned. A position determiner is provided for identifying a current position description of the needle device carrier with respect to the fixed frame of reference. A first processor is provided for calculating a needle position data set using the current position description, and a second processor is provided for calculating a composite data set by combining the patient 3D image data set and the needle device 3D image data set, wherein the needle device 3D image data set is adjusted with respect to the patient 3D image data set according to the needle position data set. A third processor is provided for calculating from the composite data set a selected set of co-ordinate locations defining a carrier guide path for movement of the needle device carrier with respect to the fixed frame of reference so that the needle device moves along a desired needle device guide path corresponding to the carrier guide path.
The needle device is selected from a group of needle devices including a biopsy needle, a needle configured for injection of toxin into diseased tissue, and an instrument configured for precision placement of a screw, and the needle device 3D image data set is selected from a group of 3D image data sets including a biopsy needle 3D image data set, an injection needle 3D image data set, and an instrument 3D image data set.
The system of the second embodiment includes a plurality of patient position markers operable for fixing relative to a patient to define a fixed frame of reference, a needle device, a needle device 3D image data set including 3D geometry of the needle device, and a needle device carrier configured for carrying the needle device for relative movement between the patient and the needle device.
The system also includes a non-ultrasonic 3D imaging subsystem operable for imaging at least a portion of the patient to provide a first patient 3D imaging data set, the first patient 3D imaging data set including positional data of the patient position markers representing a fixed frame of reference when the patient position markers are image-conspicuous, and combined with telemetry fiduciary data when telemetry readouts are arranged to correspond to successive positions of a patient to be scanned.
A 3D imaging subsystem operable is provided for imaging at least a part of the patient to provide a second patient 3D imaging data set, the part of the patient including at least some of the at least a portion of the patient, the 3D imaging subsystem being configured to use an ultrasound device to provide a second patient 3D imaging data set, the second patient 3D imaging data set being 3D data relative to the ultrasound device and not being fixed relative to the fixed frame of reference, the ultrasound device being operable to provide the second patient 3D imaging data set without relative movement between the ultrasound device and the patient.
A determiner is provided for determining position data for the ultrasound device, and a second processor is provided for using the determined position data and the second set of imaging data to calculate a converted set of imaging data corresponding to the second patient 3D imaging data set being referenced to the fixed frame of reference. A third processor is provided, the processor being operable for combining the converted set of image data with at least some of the first patient 3D imaging data set to provide a first composite imaging data set.
Also included is a position determiner operable for determining a needle device actual position and orientation data set and a fourth processor is included, the processor being operable for applying the determined needle device actual position and orientation data set to the needle device 3D image data set to form a result and for combining the result with the first composite imaging data set to produce a second composite image data set. The second composite image data set is configured for identification of the position and orientation of the needle device image relative to the first patient 3D imaging data set and determining therefrom a desired position and orientation of the needle device image corresponding to a desired actual position and orientation of the needle device relative to the patient.
Relative movement can be caused between the patient and the needle device to bring the needle device position data set into registry with the desired position and orientation of the needle device, based on the determined desired position and orientation.
As in the first embodiment, the needle device for the second embodiment is selected from a group of needle devices including a biopsy needle, a needle configured for injection of toxin into diseased tissue, and an instrument configured for precision placement of a screw, and the needle device 3D image data set is selected from a group of 3D image data sets including a biopsy needle 3D image data set, an injection needle 3D image data set, and an instrument 3D image data set.
The non-ultrasonic 3D imaging subsystem is selected from the group consisting of a computerized tomography system, a magnetic resonance system, and a fluoroscopy system. The ultrasound device can be configured to include an ultrasound probe that produces 3D imaging data without relative movement between the ultrasound probe and the patient, and includes the ultrasound probe can include a plurality of probe position markers thereon.
Optionally, the position determiner includes a subsystem to determine the position of the probe position markers and the patient position markers. Further, the system optionally includes an infrared (IR) camera.